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NCT Number: NCT07063693

ABY-029 Glioma Trial

The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach brain tumors so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.

Recruiting

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Key information

Conditions

Intracranial Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location status: Recruiting

Location contact

Linton Evans, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of presumed high-grade glioma, based on image data.
  • Tumor judged to be suitable and planned for open cranial resection.
  • Valid informed consent by participant.
  • Age ≥ 18 years old.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Prisoners
  • Individuals who are pregnant or breast feeding.
  • Participants on any experimental or approved anti-EGFR targeted therapies
  • Elevated kidney or liver function tests (levels greater than 2.5 times the normal limit) from laboratory tests conducted as part of standard-of-care screening of prospective surgical participants no earlier than 30 days prior to surgery.
  • Any condition which, in the opinion of the clinical investigator, contraindicates research participation.

Treatment and study plan

ABY-029

Drug

ABY-029 will be administered via single intravenous injection to subjects with high-grade glioma approximately 1-3 hours prior to surgery.

All research procedures will occur during surgery. The research procedures involve image and measurement data collection and biopsy specimen sampling. Research data collection will occur at 3 or 4 time points during surgery using either standard-of-care tools and methods or non-significant risk experimental devices.

No follow-up visit will be required of participants. Participants will be monitored for possible adverse events for approximately 30 days by the operating surgeon involved in the clinical trial procedures and through review of participant medical records.

Primary outcomes

  1. Adverse events related to ABY-029

    Time frame: One month

    To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences.

  2. False negative rate of ABY-029 fluorescence

    Time frame: Up to three months

    To measure of diagnostic performance of ABY-029, the false negative rate of ABY-029 fluorescence measured during surgery in tissue samples that are confirmed to be tumor through pathology.

Study contacts

Contact information is provided by the study sponsor or research team.

Keith D Paulsen, PhD

CONTACT

[email protected]

603-646-2695

Linton Evans, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College
  • National Cancer Institute (NCI)

Registry information

Official study title

Phase 1 Trial of ABY-029 Fluorescence in Patients With High-Grade Glioma

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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